Kornimate/medical-research-clean huggingface dataset:
a clinical trial to evaluate the efficacy and safety of ymc026 in respiratory disease patients

Conditions: Respiratory Disease

Summary: this is a phase 4, randomized, double-blind, multicenter clinical trial to evaluate the efficacy and safety of ymc026 in respiratory disease patients with cough and sputum as the main symptoms

the study has planned 4 visits during 2 weeks period (1 week of screening period, 1 week of treatment period). all subjects who agree to participate in the study and voluntarily give written informed consent are assessed by inclusion and exclusion criteria at the screening visit. after the screening period, the final eligibility of the subjects will be assessed at the randomization visit. subjects who are determined to be appropriate for this study will be allocated to experimental group(ymc026) or control group(placebo) randomly in a 1:1 ratio. subject will be administered the investigational product daily for 6 days. the safety for the subjects will be assessed at day 3 and day 6 visit, and the efficacy evaluation will be assessed at day 6 visit.

Eligibility criteria:
inclusion criteria: 1. both gender, 15 years ≤ age \< 75 years 2. patients with bss(bronchitis severity score) ≥ 5point at screening visit and randomization visit 3. written consent voluntarily to participate in this clinical trial exclusion criteria: 1. patients with severe respiratory disease 2. patients with severe pulmonary disease 3. patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug 4. patients with pregnant and/or have breast feeding 5. patients who were treated with monoamine oxidase inhibitor, antihistamines, anti-viral drugs and glucocorticoids within 2 weeks prior to administration of investigational product 6. patients who were treated with β2-agonist and anticholinergic drug within 1 weeks prior to administration of investigational product 7. patients who were treated with secretolytics, mucolytics and bronchodilators within 1 day prior to administration of investigational product 8. patients who are participating in another trial within 30 days prior to screening visit 9. patients who investigators determines not appropriate to take part in this clinical study
administration of iv laronidase post bone marrow transplant in hurler

Conditions: Hurler Syndrome

Summary: this is a single center pilot study in which laronidase will be given weekly for two years in patients with hurler syndrome, also known as mucopolysaccharide ih (mps i, hurler syndrome), that have previously been treated with an allogeneic transplant.

this 2-year open-label pilot study of laronidase includes patients (age 5-13 years) who are at least 2 years post-hematopoietic cell transplantation (hct) and donor engrafted. outcomes are assessed semi-annually and compared to historic controls. eligible patients will receive laronidase as an infusion over several hours once a week at a local site. the dosing of enzyme will be the standard doses recommended by genzyme. the findings of this pilot study will be used to assess whether a subsequent larger study can be conducted.

Eligibility criteria:
inclusion criteria: * mucopolysaccharidosis type ih (mps i, hurler syndrome) treated with a prior allogeneic transplant \>2 years previously * age \<14 years old * \>10% engrafted based on recent testing (\<4 months prior to enrollment) * willing to commit to traveling to the university of minnesota every 6 months * written informed consent prior to the performance of any study related procedures exclusion criteria: * previous administration of laronidase enzyme \> 3 months post transplantation * anticipated survival less than 2 years * history of cardiac or pulmonary insufficiency, including an ejection fraction (ef) \< 40% or those requiring continuous supplemental oxygen

Keywords: mucopolysaccharide ih (mps ih)
regulatory t cell with related interleukins in periodontal disease progression

Conditions: Periodontitis; Gingivitis

Summary: t regulatory cells which suppressor subset of t cells and related cytokines remain in blood and infiltrates into the tissue under need. the role of treg and related cytokines in succession of periodontal inflammation is recently a subject of research interest. chronic gingivitis and periodontitis being chronic inflammatory diseases can upregulate various cytokines in the systemic circulation and gingival crevicular fluid. this study aimed to compare levels of tregs with interleukin-21, 22, 33, 35 and vitamin d-binding protein in blood and gcf of periodontally healthy persons, chronic gingivitis patients, and severe chronic periodontitis patients.

t regs infiltration might reveal a trial to control tissue damage, however it also might be suggestive of a destructive effect of tregs in periodontitis . tregs can actually play a damaging role as this cells can annoyingly weaken the immune reaction towards infectious agents that could be possibly harmful in a periodontal environment . immunopathology of treg cell mediated via its pro-inflammatory cytokines during inflammatory conditions. il-33 "recent member of pro-inflammatory il-1 category" was recognized as placard in the stability of foxp3+ treg cell at mucosal sites. il-33 has either pro- or anti-inflammatory property according to the disease and the model. it was speculated that il-33 could improve the propagation from suppressive to dysregulated treg cells in a dose-dependent manner . interleukin (il)-21 which member of the type i (ℽ chain) cytokine family has the ability to minimize foxp3 expression and restraining treg suppressor function and homeostasis . the purpose from this study was to assess the role of circulating and localized treg with their related cytokines in patients with inflammation of periodontal tissues and to correlate their levels with disease progression.

Eligibility criteria:
inclusion criteria: * periodontally healthy persons without any signs of periodontal disease. this was determined by the absence of attachment loss and bleeding upon probing either ˂ 10% or probing depth ˂3 mm. * persons exhibiting generalized chronic gingivitis exhibiting signs of erythema, bleeding on probing up to 20%, edema, probing pocket depth less than 3 mm and no periodontal attachment loss. * persons having severe generalized form of chronic periodontitis exhibiting ppd ≥ 6 mm, cal ≥ 5mm and bone loss affecting at least six teeth as observed in dental periapical radiograph. exclusion criteria: * patients with systemic diseases according to modified cornell medical index criteria * patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection. * patients subjected to previous periodontal therapy 6 months before sampling. * patients with systemic or local inflammatory conditions other than periodontal disease. * the smokers. * neither lactating nor pregnant.

Keywords: inflammation periodontitis cytokines vitamin d-binding protein interleukin-33 nterleukin-21
the impact of person centred care (pcc) in grave's disease

Conditions: Graves Disease

Summary: mental fatigue (mf) is prevalent after graves' disease (gd), which is the most common form of hyperthyroidism. we have reported that 38% of patients, compared to 11% of control subjects, suffer from mf more than 1 year after successfully reversing of their hyperthyroidism and that mf is an entity of its own, separated from mf combined with anxiety or depression. the brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. in the new national guideline for hyperthyroidism (jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. the problem is significant for patients, as illustrated by frequent media appeals. in this project, we hypothesise that person-centred care (pcc), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves mf, reduces sick leave, and lowers the recurrence rate of gd. in two work packages (wp), we will: wp1 evaluate the effect of pcc ehealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (rct) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), mf, recurrence rate of disease, coping strategies, perceived stress, quality of life (qol) and personality. wp2 investigate the cost-effectiveness of the intervention patients with gd have impaired long-term qol. pcc could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. this is in line with the societal aim to reduce mental illness.


Eligibility criteria:
inclusion criteria: * age 18-65 years * first time graves' diseases with elevated ft4 and/or ft3 and positive tsh receptor antibody (trab) exclusion criteria: * patients that cannot attend to the protocol * patients with moderate-severe/ severe graves' eye disease

Keywords: person centred care mental fatigue cost-effectiveness self-efficacy ehealth
wellness for 2: understanding how to foster well being for mom and her baby

Conditions: Pregnancy

Summary: this nichd-funded rct will enroll up to 178 depressed pregnant women, randomly assigning them to one of 2 intervention conditions: (1) a gentle prenatal yoga program (pyp), or (2) a series of educational workshops focused on perinatal health, the mom and baby wellness workshop (mbww), each condition lasting 9 weeks. the investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

in this randomized controlled trial, eligible women will be randomly assigned to either a 9-week prenatal yoga program (pyp) vs. a 9-week health education control group, the mother-baby wellness workshop (mbww). follow up assessments will take place at multiple points during the study. the primary study outcome will be severity of prenatal depression assessed by a blind interviewer. the investigators will examine relevant secondary outcomes (self-reported depression, anxiety, functioning, \& pain; pre-term birth) and potential mediators (inflammation, mindfulness/non-judgment).

Eligibility criteria:
inclusion criteria: 1. healthy singleton pregnancy, 12-27 weeks gestation 2. medically cleared for moderate exercise 3. depression symptoms in moderate range. participants must have an quick inventory of depressive symptoms (qids; \[119\]) score between 8-20 4. english-speaking 5. aged 18 or older exclusion criteria: 1. new or unstable depression treatment 2. currently a regular yoga practitioner 3. bipolar disorder, schizophrenia, psychotic depression, chronic psychosis 4. current hazardous drug or alcohol use 5. acute suicidality
addition of a focal boost in external beam radiotherapy for locally advanced prostate cancer by online adaptive mr-guided radiotherapy

Conditions: Prostate Cancer; Prostate Neoplasm

Summary: the affirm trial tests the safety and clinical feasibility of mr-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. external beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.the long-term results of the multicentre phase iii study (flame trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life. this focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). the current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. for locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.


Eligibility criteria:
inclusion criteria: * men aged 18 years or older with histologically proven prostate carcinoma * imaging stage t3b (as defined on mpmri) n0m0 * intraprostatic lesion visible on mri * capable of giving informed consent exclusion criteria: * history of radiotherapy to the pelvis or transurethral resection of the prostate (turp) * contraindications for mri according to the guidelines of the local department of radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia * absence of pre-treatment psma pet ct * who performance score \> 2 * international prostate symptom score ≥ 15 * psa \> 30 * prostate volume \>100c
development of a tele-monitoring program for patients undergoing surgery for pheochromocytoma and / or paraganglioma

Conditions: Pheochromocytoma; Paraganglioma

Summary: pheochromocytomas and paragangliomas (ppgl) are rare tumors treated by surgical excision. during follow-up, more than 15% of patients will have recurrences in the form of new tumors, locoregional recurrence or metastases. this subgroup is initially not identifiable. it is therefore usual to perform annual monitoring of all patients throughout their lives by questioning and measuring blood pressure during a medical consultation and by measuring urinary or plasma metanephrines and normetanephrines. the main objective of this prospective monocentric study is to evaluate the reliability of an optimized remote monitoring program in comparison to a usual in-clinic monitoring of patients surgically-cured and tumor-free at the time of inclusion.

patients will be included in a follow-up consultation or during a telephone contact prior to a consultation. the period of follow-up by internet and the date of the next consultation will be fixed. this assessment is annual according to current recommendations. in the two months prior to the consultation, patients will fill out a questionnaire and transcribe their blood pressure self-measurement results as well as their biological assessment on a dedicated, approved data-hosting platform (internet application named hermes). during the consultation, these items will be collected again without the knowledge of the results entered by the patient on the data hosting site.

Eligibility criteria:
inclusion criteria: * patient at least 18 years old * follow-up after surgery of a pheochromocytoma or a paraganglioma at the european hospital georges pompidou (paris, france) * free from recurrences and / or metastases at inclusion * non-opposition of participation in research exclusion criteria: * lack of internet access * patient not understanding french * patient living abroad, unable to come for consultation * patient with co-morbidity involving life threatening within one year of inclusion * pregnant or breastfeeding woman

Keywords: follow-up recurrence e-consultation pheochromocytoma
the efficacy of different anti-viral drugs in covid 19 infected patients

Conditions: SARS-CoV Infection; COVID 19; Acute Respiratory Distress Syndrome ARDS

Summary: the (world health organization) who nor- (coronavirus infectious disease) covid 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with covid-19. this trial will follow the core who protocol but has additional efficacy, safety and explorative endpoints.


Eligibility criteria:
inclusion criteria: 1. adult patients, 18 years and above 2. confirmed sars-2-cov-2 infection by pcr 3. admitted to the hospital ward or the icu 4. subjects (or legally authorized representative) provides written informed consent prior to initiation of the study exclusion criteria: 1. severe co-morbidity with life expectancy \<3 months according to investigators assessment 2. (aspartate transaminase/ alanine aminotransferase) asat/alat \> 5 times the upper limit of normal 3. acute co-morbidity within 7 days before inclusion such as myocardial infarction 4. known intolerance to the available study drugs 5. pregnancy, possible pregnancy or breast feeding 6. any reason why, in the opinion of the investigators, the patient should not participate 7. subject participates in a potentially confounding drug or device trial during the course of the study 8. prolonged qt interval (\>450 ms)

Keywords: effect of drugs adverse effects of drugs sars-cov clearance duration of artificial ventilation duration of intensive care stay duration of hospital stay
performance evaluation of tb breath- and cough-testing platforms

Conditions: Pulmonary TB; Diagnoses Diseases

Summary: this will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy of two tb breath-based technologies independently of the manufacturers. assay error and failure rates and device operational characteristics will also be assessed during this study. participants will be enrolled in this study in line with find sample banking activities. results from index tests will not be used to make clinical decisions. participation in this study will not alter the standard of care.


Eligibility criteria:
inclusion criteria: * symptoms suggesting pulmonary tb, i.e. persistent cough (generally \> 3 weeks or as per local definition of tb suspect) and at least one other finding listed below: 1. persistent cough 2. fever 3. malaise 4. recent weight loss 5. night sweats 6. contact w/ active case 7. hemoptysis 8. chest pain 9. loss of appetite 10. other \[specify\] * provision of informed consent to sample collection, banking and hiv and breath-based assay testing * production of adequate quantity of sputum (sputum induction whenever possible) * adult age (\>18 years old) exclusion criteria: * participants receiving any anti-tuberculosis medication, including fluoroquinolone and aminoglycosides in the 60 days prior to enrolment. * participants with only extra-pulmonary disease will be excluded. * participants for whom complete follow-up and a clear final diagnosis are judged to be difficult (e.g. residents elsewhere or about to move).
cell free dna and its integrity using alu sequences as a biomarker for diagnosis of breast cancer

Conditions: Breast Cancer

Summary: breast cancer (bc) is the most common cancer in women worldwide, and is the leading cause of death from cancer among women globally. mammography is the standard method for early detection of bc in many countries, with over 1.3 million annually new diagnosed cases.in egypt, breast cancer is the most common cancer in females accounting for 38.8% of all female cancers.

breast cancer (bc) is the most common cancer in women worldwide, and is the leading cause of death from cancer among women globally. mammography is the standard method for early detection of bc in many countries, with over 1.3 million annually new diagnosed cases.in egypt, breast cancer is the most common cancer in females accounting for 38.8% of all female cancers. whereas radiological screening programs have been successfully applied in detecting breast cancer in earlier stages, no valuable blood biomarkers have been yet identified for that purpose. however, false-positive recall rates vary according to age, breast density, and postmenopausal hormonal therapy, among other. for women with dense breasts, the accuracy of mammography is decreased. circulating serum marker for monitoring of bc have been in development for several decades. conventional tumor markers, such as cancer antigen 15-3 (ca15-3), carcinoembryonic antigen (cea)), and circulating tumor cell count (ctc), are clinically available, however, their usefulness is mostly limited to patients with advanced and metastatic bc (mbc). hence, there is a need for developing new biomarkers which can be used as valuable tools in identifying high risk patients, to predict disease prognosis and thus have an impact in patient management.cell free dna (cfdna) are short fragments of nucleic acids present in the circulation. multiple studies also have indicated elevated levels of cf dna in breast cancer. the alu(arthrobacter luteus) sequences were chosen, as they are the most abundant and active repeated elements in the human genome, typically 300 nucleotides in length, accounting for more than 10% of the genome. dna integrity was calculated as the ratio of (alu247/alu115). as the annealing sites of alu115 are within the alu247 annealing sites, thus the ratio of alu247 to alu115 is termed as dna integrity. it characterizes the fragmentation pattern of circulating cell free dna. the dna integrity is "1" if template dna is not truncated and "0" if dna is completely truncated to fragments smaller than 247 bp (base pair). thus it has been assessed for its diagnostic and prognostic potential role in breast cancer patients

Eligibility criteria:
inclusion criteria: * all patients enrolled before initiation of any treatment. exclusion criteria: * any other malignant or benign tumors. * active inflammatory or autoimmune diseases. * renal or liver diseases.
the effect of perineural dextrose injection in patients with ulnar neuropathy at the elbow

Conditions: Ulnar Neuropathies

Summary: ulnar neuropathy at the elbow (une) is the second most common neuropathy and occurs after recurrent or elongated elbow flexion. diagnosis of une depends on clinical symptoms, physical examination, and electrophysiological findings. imaging methods such as ultrasonography (usg) and magnetic resonance imaging show cross-sectional area and echogenicity of ulnar nerve and give information about to surrounding structures around the ulnar nerve. in mild and moderate cases, conservative treatments are administered up to 6 months, who do not benefit from conservative treatment are referred to surgery. there are not many options for conservative treatment. activity modification, nerve gliding exercises and night splints are conservative treatment methods. steroid injection is no longer recommended. perineural dextrose injection is applied in tendinopathies and entrapment neuropathies (especially carpal tunnel syndrome). in the literature, there is no study showing effect of perineural dextrose injection in patients with une. the investigators design a randomized, double-blind, controlled trail to evaluate the effect after ultrasound-guided perineural injection with 5% dextrose in patients with une.

after obtaining written informed consent, patients of clinically diagnosed with une were randomized into intervention and control group. participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. no additional treatment after injection through the study period. the primary outcome is visual analog scale (vas) and secondary outcomes include quick-dash (disabilities of arm, shoulder and hand), cross-sectional area (csa) of the ulnar nerve, motor nerve conduction velocity and distal latency of the ulnar nerve. the evaluation was performed pretreatment as well as on the 2nd week, 1st and 3rd month after the treatment.

Eligibility criteria:
inclusion criteria: * age between 18-65 year-old. * neuropathic pain on the ulnar nerve distribution area for at least 1 months * diagnosis was confirmed using an electrophysiological studies and ultrasonography exclusion criteria: * history of trauma to the upper extremity * central or peripheral neurologic disease * electromyography (emg)-proven carpal tunnel syndrome, radiculopathy or any other neuropathy * pregnancy or any systemic disease that might cause swelling on nerves (e.g., diabetes -mellitus, renal failure, and thyroid disease) * usg-detected bifid or trifid median nerve, persistent median artery, or space-occupying lesions